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GMP Clinical Manufacturing

CDMO expertise for GMP clinical manufacturing. Upperton has extensive capabilities in GMP clinical manufacturing, and is able to produce IMPs for clinical trials between phase I and Phase III.

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GMP Manufacturing At Upperton

GMP manufacturing is the strictly regulated production of investigational medical products (IMPs) for clinical trials between phase 1 and phase 3 clinical trials. GMP facilities are essential for determining small batch flexibility and alignment with key regulatory bodies including the MHRA and the FDA. Effective clinical manufacturing is essential for moving IMPs from development, successfully through clinical trials and into patients. 

Our model is built around:

  • One-site delivery for seamless project execution
  • Embedded senior leadership on every project
  • Scalable science that evolves with your programme
  • Flexible, responsive partnerships tailored to biotech needs

When you are ready to begin your CDMO journey, Upperton specialises in:

Inhalation drug products (pulmonary delivery)
Oral solid dosage form tablets and capsules
Oral solid dosage forms (OSD)
Nasal drug delivery systems
Parenteral formulations

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GMP Capabilities At Upperton

  • Tech transfer
  • GMP clinical manufacturing
  • Cleanroom infrastructure
  • GMP support services
  • Flexible batch configurations
  • End-to-end technology
Manufacturing

10 Individual GMP Manufacturing Suites

Spray Drying

100ml – 10kg Batch Sizes

Dry Granulation

Up to 100kg Per Hour

Tabletting

Up to 1,000,000 Tablets Per Day

Tablet Coating

5kg – 50kg Batch Sizes

Capsule Filling

Up to 350,000 Capsules Per Day

Blending

Up to 250kg Capacity

Blister Packaging

Up to 2,000 Units Per Day

Facility

50,000 sq ft CDMO Facility

Containment

High Potency Containment

Regulatory

MHRA Approved

Controlled Substances

Home Office Approved (Schedule 1–4)

GMP CLinical Manufacturing

GMP Facilities for a wide range of molecules

At Upperton, our GMP facilities are built to handle a wide range of molecules. Equipped with state-of-the-art technology, our GMP facilities include 10 advanced GMP manufacturing suites process trains to support oral, pulmonary and nasal dosage forms, flexible manufacturing, sterile processing capability and clinical packaging and labelling.  Within our facility, we can also handle high potency containment, in which we are able to handle OEB4 and OEB5 pharmaceutical compounds, subject to individual project requirements. Our experts can advise on projects on a case-by-case basis.  

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UK Pharma Awards:

Contract Services Company of the Year

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Medilink Midlands:

Innovation of the Year

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Medilink Midlands:

Outstanding Achievement Award

Why Upperton

At Upperton, we specialise in the formulation and development of complex molecules, supporting a wide range of advanced drug delivery systems.

Our expertise spans:

By combining scientific excellence with practical development expertise, we help overcome the challenges of complex drug products and accelerate their path to clinic and market.

partnership

Why Partner with Upperton

We provide fully integrated services across every stage of drug product development:

Microscope and analysis equipment at the Upperton facility

One Site

Integrated, end-to-end capabilities delivered under one roof.

Upperton scientist examining a formulation flask

One Team

The same team from your early-stage development through to preparation for commercial launch.

Test tubes used in complex molecule formulation development

Complex Molecule Expertise:

Proven track record in solving formulation and delivery challenges.

Upperton senior leadership overseeing laboratory work

Executive Leadership on Every Project:

Direct access to experienced senior leadership for strategic oversight and decision-making.

Got questions around GMP Manufacturing?

Speak to our SME team about your project.

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Related Services

·   Process Scale Up
·   Packaging and QP Release

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Related Content

·  Choosing your Outsourcing CDMO Partner
·  Your Essential Guide to Clinical Trial Manufacturing

GMP Clinical Manufacturing FAQs

We are a Home Office Approved Facility for Schedule 1-4 drugs, and can handle OEB4/5 pharmaceutical compounds subject to individual project requirements.  

GMP‑compliant clinical manufacturing refers to the controlled production of investigational medicinal products using validated processes, qualified equipment, controlled environments, and fully traceable documentation. Every step from material sourcing to batch release must meet regulatory expectations to ensure patient safety, reproducibility, and data integrity. 

Phase‑appropriate GMP aligns the depth of process validation, analytical method robustness, impurity control, and process understanding with the stage of clinical development. Early phases prioritise scientific justification and process qualification, while later stages demand higher levels of validation and reproducibility. Upperton applies a scalable, phase‑appropriate quality framework that evolves with your molecule as it advances through the clinic. 

A QMS safeguards product quality by governing documentation, training, deviation management, change control, CAPA actions, internal audits, and supplier oversight. It ensures all activities are consistent, traceable, and aligned with regulatory requirements. Upperton’s QMS provides full lifecycle oversight, ensuring every activity from development to GMP manufacture meets stringent quality standards. 

Facilities must maintain controlled environmental conditions with appropriate airflow, pressure differentials, contamination control, and monitoring systems. Equipment must undergo installation, operational, and performance qualification, with ongoing calibration and validated cleaning practices. Upperton operates modern, fully qualified manufacturing suites with validated equipment and environmental systems designed specifically for clinical‑stage production. 

Raw materials require supplier qualification, identity verification, controlled storage, traceability, and testing according to predefined specifications. Only approved and released materials may enter the manufacturing process to ensure batch consistency and patient safety. Upperton enforces rigorous material control procedures, from supplier assessment to in‑house verification, ensuring only compliant materials enter GMP operations. 

Early phases rely on process qualification and risk‑based justification rather than full validation. As the product progresses, deeper process understanding, control‑strategy refinement, and reproducibility across multiple batches become mandatory to support regulatory expectations. Upperton builds process knowledge from development through manufacture, enabling a smooth progression toward full validation in later clinical stages. 

Microbial control is maintained through cleanroom classification, environmental monitoring, aseptic practices, validated sterilisation or microbial‑reduction steps, and strict adherence to contamination‑control procedures. Continuous monitoring ensures conditions remain within predefined limits. How Upperton supports this: Upperton implements robust environmental controls and contamination‑prevention practices that safeguard product quality at every stage. 

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We provide fully integrated services across every stage of drug product development.

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